Systems and methods for treating aneurysms

ABSTRACT

An apparatus for treating an aneurysm in a blood vessel includes an occlusion element configured to be releasably coupled to an elongate delivery shaft and configured to be delivered in a collapsed configuration through an inner lumen of a delivery catheter, the occlusion element including an inverted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an inversion fold, wherein at least the outer layer is formed into a first expanded shape including: a smooth outer cylinder configured to engage a wall of an aneurysm throughout a 360° circumference; and a substantially distal-facing surface including one or more heat-formed undulations, the one or more undulations configured to apply a radial force on the wall of the aneurysm.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is continuation of U.S. patent application Ser. No.18/353,880, filed on Jul. 17, 2023, which is a continuation ofinternational application no. PCT/US2022/013986, filed on Jan. 27, 2022,which claims the benefit of priority to U.S. Provisional Application No.63/142,480, filed on Jan. 27, 2021, and U.S. Provisional Application No.63/312,030, filed on Jun. 21, 2021, all of which are incorporated byreference in their entirety herein for all purposes. Priority is claimedpursuant to 35 U.S.C. § 120 and 35 U.S.C. § 119.

BACKGROUND OF THE INVENTION Field of the Invention

The field of the invention generally relates to embolic devices forfilling spaces in the vascular system, including cerebral aneurysms orleft atrial appendages. In some case, the embolic devices may be used toembolize native vessels.

Description of the Related Art

An embolic device may be used as a stand-alone device to occlude andaneurysm, or may be used with an adjunctive device or material.

SUMMARY OF THE INVENTION

In one embodiment of the present disclosure, an apparatus for treatingan aneurysm in a blood vessel includes an occlusion element configuredto be releasably coupled to an elongate delivery shaft and configured tobe delivered in a collapsed configuration through an inner lumen of adelivery catheter, the occlusion element including an inverted mesh tubehaving an outer layer and an inner layer, the outer layer transitioningto the inner layer at an inversion fold, wherein at least the outerlayer is formed into a first expanded shape including: a smooth outercylinder configured to engage a wall of an aneurysm throughout a 360°circumference; and a substantially distal-facing surface including oneor more heat-formed undulations, the one or more undulations configuredto apply a radial force on the wall of the aneurysm.

In another embodiment of the present disclosure, an apparatus fortreating an aneurysm in a blood vessel includes an occlusion elementconfigured to be releasably coupled to an elongate delivery shaft andconfigured to be delivered in a collapsed configuration through an innerlumen of a delivery catheter, the occlusion element including aninverted mesh tube having an outer layer and an inner layer, the outerlayer transitioning to the inner layer at an inversion fold, wherein atleast the outer layer is formed into a first expanded shape including anouter lateral surface extending around the occlusion element, and asubstantially distal-facing surface including one or more heat-formedundulations, the one or more undulations configured to apply a radialforce on a wall of an aneurysm.

In yet another embodiment of the present disclosure, an apparatus fortreating an aneurysm in a blood vessel includes an occlusion elementconfigured to be releasably coupled to an elongate delivery shaft andconfigured to be delivered in a collapsed configuration through an innerlumen of a delivery catheter, the occlusion element including aninverted mesh tube having an outer layer and an inner layer, the outerlayer transitioning to the inner layer at an inversion fold, wherein atleast the outer layer is formed into a first expanded shape having afirst diameter, wherein the inner layer is formed into a second expandedshape contained within the first expanded shape, the second expandedshape having a second diameter.

In still another embodiment of the present disclosure, an occlusiondevice for treating an aneurysm in a blood vessel includes a bodyconfigured to be releasably coupled to an elongate delivery shaft andconfigured to be delivered in a collapsed configuration through an innerlumen of a delivery catheter, the body further configured to expand toan expanded configuration when delivered out of the inner lumen of thedelivery catheter, the body including an inverted mesh tube having anouter layer and an inner layer, the outer layer transitioning to theinner layer at an inversion fold, wherein the outer layer includes aglobular portion and wherein the inner layer includes a first proximalinner cover portion within a proximal end of the globular portion andwherein the inner layer further includes a distal columnar portionextending from the first proximal inner cover portion.

In yet another embodiment of the present disclosure, occlusion devicefor treating an aneurysm in a blood vessel includes a body configured tobe releasably coupled to an elongate delivery shaft and configured to bedelivered in a collapsed configuration through an inner lumen of adelivery catheter, the body further configured to expand to an expandedconfiguration when delivered out of the inner lumen of the deliverycatheter, the body including an inverted mesh tube having an outer layerand an inner layer, the outer layer transitioning to the inner layer atan inversion fold, wherein the outer layer includes a first proximalcover portion having a cover diameter and a first distal globularportion extending distally from the cover portion, and wherein the innerlayer includes a second proximal cover portion within the first proximalcover portion and a second distal globular portion within the firstdistal globular portion.

In still another embodiment of the present disclosure, an occlusiondevice for treating an aneurism in a blood vessel includes a bodyconfigured to be releasably coupled to an elongate delivery shaft andconfigured to be delivered in a collapsed configuration through an innerlumen of a delivery catheter, the body further configured to expand toan expanded configuration when delivered out of the inner lumen of thedelivery catheter, the body including an inverted mesh tube having anouter layer and an inner layer, the outer layer transitioning to theinner layer at an inversion fold, wherein the outer layer includes aglobular portion and wherein the inner layer includes a proximal innercover portion within a proximal end of the globular portion and whereinthe inner layer further includes a distal inner cover portion extendingfrom the proximal inner cover portion, the distal portion having asignificantly smaller diameter than the proximal inner cover portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an occlusion device, according to anembodiment of the present disclosure.

FIG. 2 is a sectional view of the occlusion device of FIG. 1 .

FIG. 3A is a perspective view of a first alternative shape of anocclusion device, according to an embodiment of the present disclosure.

FIG. 3B is a side view of the occlusion device of FIG. 3A.

FIG. 4A is a perspective view of a second alternative shape of anocclusion device, according to an embodiment of the present disclosure.

FIG. 4B is a side view of the occlusion device of FIG. 4A.

FIG. 5A is a perspective view of a third alternative shape of anocclusion device, according to an embodiment of the present disclosure.

FIG. 5B is a side view of the occlusion device of FIG. 5A.

FIG. 6A is a perspective view of a fourth alternative shape of anocclusion device, according to an embodiment of the present disclosure.

FIG. 6B is a side view of the occlusion device of FIG. 6A.

FIGS. 7-10 illustrate the implantation of the occlusion device of FIG. 1in an aneurysm of a blood vessel of a patient.

FIG. 11 is a sectional view of an alternative occlusion device,according to an embodiment of the present disclosure.

FIG. 12A is a perspective view of an occlusion device, according to anembodiment of the present disclosure.

FIG. 12B is another perspective view of the occlusion device of FIG.12A.

FIG. 13 is a sectional view of the occlusion device of FIG. 12A.

FIGS. 14-18 illustrate the deployment of the occlusion device of FIG.12A from a delivery catheter.

FIG. 19 is a perspective view of an occlusion device, according to analternative embodiment of the present disclosure.

FIG. 20 is a perspective view of an occlusion device, according to analternative embodiment of the present disclosure.

FIG. 21 is another perspective view of the occlusion device of FIG. 20 .

FIG. 22 is a sectional view of the occlusion device of FIG. 20 .

FIGS. 23-28 illustrate the deployment of the occlusion device of FIG. 20from a delivery catheter.

FIG. 29 is a perspective view of an occlusion device, according to anembodiment of the present disclosure.

FIG. 30 is a sectional view of the occlusion device of FIG. 29 .

FIG. 31 is a perspective view of an occlusion device, according to anembodiment of the present disclosure.

FIGS. 32-36 illustrate the deployment of the occlusion device of FIG. 29from a delivery catheter.

FIG. 37 illustrates is a sectional view of an alternative occlusiondevice configuration according to an embodiment of the presentdisclosure.

FIG. 38 is a perspective view of an occlusion device, according to anembodiment of the present disclosure.

FIG. 39 is a sectional view of the occlusion device of FIG. 38 .

FIGS. 40-46 illustrate the deployment of the occlusion device of FIG. 38from a delivery catheter.

FIG. 47 is a perspective view of an occlusion device, according to anembodiment of the present disclosure.

FIG. 48 is a sectional view of the occlusion device of FIG. 47 .

FIGS. 49-56 illustrate the deployment of the occlusion device of FIG. 47from a delivery catheter.

FIG. 57 is a perspective view of an occlusion device, according to anembodiment of the present disclosure.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Aneurysms are abnormal bulging or weakening of a blood vessel, often anartery, and can have many complications. A bulging of the blood vesselcan disrupt or put pressure on surrounding tissues. Cerebral aneurysmscan result in a variety of side effects, such as impaired vision,impaired speech, impaired balance, etc. Further, the aneurysm creates avolume that is not along the main flow path of the blood through theblood vessel. It therefore can serve as a location for blood to becomestagnant and, due to swirling eddy currents, can contribute to theformation of a thromboembolism. If an aneurysm ruptures, it can causesevere internal bleeding, which in cerebral arteries can often becomefatal.

Aneurysms can be treated externally with open surgery. Such procedurestypically involve closing off the entrance or “neck” of the aneurysmwith a device such as vascular clip, clamp or a ligature. However, suchopen surgical procedures can be highly invasive and may lead to traumato the adjacent tissue and other side effects.

Aneurysms can also be treated through endovascular procedures. In oneprocedure, detachable lengths of wires (e.g., coils) are inserted intothe interior volume of the aneurysm using a catheter. The coils areintended to fill the volume of the aneurysm to decrease the flow ofblood into the aneurysm, inducing stagnation of flow and stimulateclotting within the aneurysm. In settings of large cerebral aneurysms,filling of the aneurysm with multiple coils can lead to mass effect thatmay induce brain swelling and be an independent cause for new symptoms.In another procedure, for aneurysms with a relatively large neck, theadjunctive use of stents assists with the retention of the coils withinthe aneurysm. This approach may have a contraindication to being usedwhen treating ruptured aneurysm, due to the need for additionalanti-thrombotic medications. In another procedure, the coils are held inthe volume of the aneurysm with a temporary balloon that is inflated inthe blood vessel. The balloon is deflated and removed once the mass ofcoils is secured. In still another procedure, a stent device is placedin the artery to promote flow of blood past the aneurysm. This leads tostagnation of the blood within the aneurysm and thrombosis inside theaneurysm volume. However, a side branch of a main artery in which thestent device is placed may become trapped or “jailed,” which can impedeaccess to the side branch. In other instances, the side branch canbecome clotted off, possibly causing a stroke. Additionally, such aprocedure generally requires the use additional anti-thromboticmedications, which limits the use of such devices in the setting oftreatment of ruptured aneurysms. The stent device is often formed with arelatively tight weave. While the tight weave increases theeffectiveness of the stent device in diverting the blood flow, it alsoimpedes or prevents access to the volume of the aneurysm or the jailedartery. In the event that the aneurysm fails to clot, the obstruction ofthe aneurysm by the stent device prevents the possibility of placingembolic devices inside the aneurysm. Additional procedures such as theplacement of additional stents or open surgery may then be required totreat the residual.

Procedures that involve packing the volume of the aneurysm can sufferfrom several common shortcomings. First, it can take many coils of wireto fill the volume of the aneurysm, which is time consuming andincreases the time it takes to complete the procedure. Further, thecoils may be compacted over time to occupy a smaller percentage of thetotal volume of the aneurysm. A great enough compaction of the coils canbe considered a recurrence of the aneurysm and may require furthertreatment.

FIG. 1 illustrates an occlusion device 200 configured for placementwithin an aneurysm. The occlusion device 200 comprises a proximal end202 and a distal end 230, and is constructed of a single, continuousdual layer mesh 266. Turning to FIG. 2 , the occlusion device 200 isconstructed from an inverted mesh tube 206 having a first end 208, asecond end 210, and a wall 209. The inverted mesh tube 206 extends on anouter layer 212 of the inverted mesh tube 206, from the second end 210past a proximal concavity 215 along a convex proximal surface 214 andalong a smooth cylindrical section 216 to the distal end 230 of theocclusion device 200. The smooth cylindrical section 216 is configuredto provide full 360° contact with the inner wall of an aneurysm (aroundthe longitudinal axis 211 of the occlusion device 200), to form acylindrical closure region with the aneurysm. The outer diameter of thesmooth cylindrical section 216 may be between about 3 mm to about 15 mm,or between about 3 mm and about 7 mm. At the distal end 230, the wall209 is inverted inwardly at an inversion fold 232, which creates adistal orifice 234 and an internal volume 236. The wall 209 transitionsat the inversion fold 232 from the outer layer 212 to an inner layer 238which follows the contours of the outer layer 212 from the distalorifice 234 to the first end 208. The inner layer 238 follows thecontours of the distal end 230, the smooth cylindrical section 216, theconvex proximal surface 214, and the proximal concavity 215. In theembodiment of FIG. 2 , the outer layer 212 and the inner layer 238 aresubstantially flush in relation to each other. The occlusion device 200is fabricated as an inverted mesh tube 206 having a simple straightelongate configuration, and is subsequently formed into the shape shownin FIGS. 1 and 2 and heat set into this shape. For example, theocclusion device 200 can be constructed as a single layer mesh tubeformed of at least some nickel-titanium alloy filaments, and theninverted on itself. The inverted mesh tube 206 can then be placed into adie or mold comprising one or more pieces, to hold it in the shape ofthe occlusion device 200. Then, the occlusion device 200 can besubjected to an elevated temperature and then cooled, to lock in theshape, resulting in an occlusion device 200 having at least somesuperelastic properties. The occlusion device 200 is configured to becompressed or compacted within the lumen 148 of a delivery catheter 150(e.g., microcatheter) (see FIG. 7 ).

In some embodiments, the occlusion device 200 may comprise somenickel-titanium alloy filaments and some radiopaque elements, comprisingplatinum, gold, tantalum, or alloys of any of these or other radiopaquematerials. In some embodiments, the filaments may comprise drawn filledtubes, such as those comprising a nickel-titanium alloy outer wall and aplatinum core. The radiopaque material allows the occlusion device 200to be visible on radiographs or fluoroscopy. The occlusion device 200may be configured by controlling how much radiopaque material is used,by either the ratio of radiopaque filaments to non-radiopaque filaments,or by the amount of platinum core in the drawn filled tubes. In thismanner, the occlusion device 200 can be selectively fabricated to besufficiently visible, but not over visible, e.g., overly bright, suchthat other objects are obscured. In some embodiments, whether any of thefilaments comprise radiopaque materials or not, a marker band 217 can beattached adjacent the proximal end 202 by adhesive or epoxy bonding, orswaging, welding or other mechanical attachment. As shown in FIGS. 1-2 ,the marker band 217 can be configured to partially or completely residewithin the proximal concavity 215 of the expanded occlusion device 200.The occlusion device 200 is detachably coupled at a detachable joint225, at or adjacent its proximal end 202, to a pusher wire 219 having adistal end 221 and a proximal end 223. The detachable joint 225 cancomprise one of a number of detachment systems, including but notlimited to pressurized detachment, electrolytic detachment mechanisms,hydraulic detachment mechanisms, mechanical or interlocking detachmentmechanisms, chemical detachment mechanisms, heat-activated detachmentsystems, or frictional detachment systems. In any of the embodimentsdisclosed herein, alternative detachable joint may be employed, such asthe detachable joints disclosed in U.S. Pat. No. 11,058,431, issued Jul.13, 2021, and entitled “Systems and Methods for Treating Aneurysms” andin U.S. Pat. No. 10,856,880, issued Dec. 8, 2020, and entitled “Systemsand Methods for Treating Aneurysms,” both of which are herebyincorporated by reference in their entirety for all purposes.

The occlusion device 200 is heat set into the shape shown in FIGS. 1-2using male and/or female forms or molds, to create a wavy shape 262 on adistal surface 260 of the distal end 230. The distal surface 260 may begenerally thought of as the “end” of a cylinder, although the shape ofthe distal surface 260 is not planar. The wavy shape 262 includes aseries of curvilinear contours 264 along the distal surface 260. Themale and/or female forms or molds have mating shapes such that theexpanded mesh is held with the distal surface 260 in these contoursduring the heat set process. The forms or molds are then removed afterthe shape memory/nickel-titanium mesh 266 has been heated to a settemperature and then cooled. The combination of the smooth circumferenceof the smooth cylindrical section 216 and the wavy shape 262 of thedistal surface 260 in a single occlusion device 200 provides an implantthat is configured to seal or close the aneurysm wall, but is alsoconfigured to provide an increased radial force to allow stabilizationof the implant within the aneurysm. The curvilinear contours 264 in themesh 266 provide a spring-like bias in a radial direction, that wouldnot be present or would be less present if the distal surface 260 wereinstead formed as a flat disk or planar shape. The curvilinear contours264 provide radial forces to create a good anchor against the wall ofthe aneurysm, which, along with the contact of the smooth cylindricalsection 216, helps prevent endoleak, by forming an effective closure.

The curvilinear contours 264 may take a wide variety of forms, whendescribed in a two-dimensional basis (e.g, in cross-section) or whendescribed in a three-dimensional basis (surface contour). In someembodiments, the curvilinear contours 264 may comprise true wave shapes,and in other embodiments, the curvilinear contours 264 may comprisepseudo-wave shapes. In both cases, the shape may be described as “wavy”or “undulating.” In the embodiments wherein a true wave is representedin the shape (e.g., along a particular axis), the wave may in someembodiments be sinusoidal, and in other embodiments be non-sinusoidal.In some embodiments, the wave-shape may be continuous (e.g., across thesurface), and in other embodiments, the wave-shape may be discontinuousor interrupted. In some embodiments, the wave-shape may increase infrequency in one direction (or likewise, decreasing in frequency in theother direction); for example, along a particular axis or along aparticular transverse plane. In some embodiments, the wave-shape maymaintain a substantially consistent amplitude (e.g., peak height)throughout, and in other embodiments, the amplitude may have a “damped”appearance and may increase or decrease along a particular axis or alonga particular transverse plane. In some embodiments, thethree-dimensional surface contour of the distal surface 260 may comprisea section comprising two or more wave shapes having a convex or concavesurface between them. In some embodiments, the two or more wave shapesmay be substantially parallel to each other, or may be substantiallynon-parallel to each other. For example, a convex wave peak may beadjacent a concave surface. Or, a concave peak may be adjacent a convexsurface.

FIGS. 3A-6B illustrate occlusion devices similar to the occlusion device200 of FIGS. 1-2 , but with different shapes and dimensions. FIGS. 3A-3Billustrate an occlusion device 268 having a ratio of smooth cylindricalsection 270 height H_(C) to total height H_(T) (ratio=H_(C)/H_(T)) equalto between about 0.42 and about 0.48, or equal to about 0.45. Theocclusion device 268 has a ratio of curvilinear contour 272 height H_(W)to total height H_(T) (ratio=H_(W)/H_(T)) equal to between about 0.52and about 0.58, or equal to about 0.55. The occlusion device 268 has acurvilinear contour 272 that extends around an outer circumference ofthe distal end 274. A maximum diameter D_(M) of the occlusion device 268occurs at an upper extreme 276 of the smooth cylindrical section 270. Aminimum diameter D_(m) of the occlusion device 268 occurs at a lowerextreme 278 of the smooth cylindrical section 270. Thus, the smoothcylindrical section 270 is a frustoconical surface providing a taperingdiameter, that tapers up (increasingly in diameter) toward thecurvilinear contour 272. The occlusion device 268 has a ratio of totalheight H_(T) to maximum diameter D_(M) (ratio=H_(T)/D_(M)) equal tobetween about 0.25 and about 0.57, or between about 0.35 and about 0.49,or equal to about 0.42. The occlusion device 268 is formed using afemale form or mold that engages the distal surface 280.

FIGS. 4A-4B illustrate an occlusion device 282 having a ratio of smoothcylindrical section 284 height H_(C) to total height H_(T)(ratio=H_(C)/H_(T)) equal to between about 0.47 and about or equal toabout 0.50. The occlusion device 282 has a ratio of curvilinear contour286 height H_(W) to total height H_(T) (ratio=H_(W)/H_(T)) equal tobetween about 0.47 and about 0.55, or equal to about 0.50. The occlusiondevice 282 has a curvilinear contour 286 that extends around an outercircumference of the distal end 288. A maximum diameter D_(M) of theocclusion device 282 occurs at an upper extreme 290 of the smoothcylindrical section 284. A minimum diameter D_(m) of the occlusiondevice 282 occurs at a lower extreme 292 of the smooth cylindricalsection 284. Thus, the smooth cylindrical section 284 is a frustoconicalsurface providing a tapering diameter, that tapers up toward thecurvilinear contour 286. The occlusion device 282 has a ratio of totalheight H_(T) to maximum diameter D_(M) (ratio=H_(T)/D_(M)) equal tobetween about 0.25 and about 0.57, or between about 0.36 and about 0.50,or equal to about 0.41. The occlusion device 282 is formed using a maleform or mold that engages the distal surface 291.

FIGS. 5A-5B illustrate an occlusion device 294 having a ratio of smoothcylindrical section 296 height H_(C) to total height H_(T)(ratio=H_(C)/H_(T)) equal to between about 0.59 and about or equal toabout 0.625. The occlusion device 294 has a ratio of curvilinear contour298 height H_(W) to total height H_(T) (ratio=H_(W)/H_(T)) equal tobetween about 0.34 and about 0.41, or equal to about 0.375. Theocclusion device 294 has a curvilinear contour 298 that extends aroundan outer circumference of the distal end 299. A maximum diameter D_(M)of the occlusion device 294 occurs at an upper extreme 297 of the smoothcylindrical section 296. A minimum diameter D_(m) of the occlusiondevice 294 occurs at a lower extreme 295 of the smooth cylindricalsection 296. Thus, the smooth cylindrical section 296 is a frustoconicalsurface providing a tapering diameter, that tapers up toward thecurvilinear contour 298. The occlusion device 294 has a ratio of totalheight H_(T) to maximum diameter D_(M) (ratio=H_(T)/D_(M)) equal tobetween about 0.20 and about 0.52, or between about 0.31 and about 0.45,or equal to about 0.36. The occlusion device 294 is formed using afemale form or mold that engages the distal surface 293.

FIGS. 6A-6B illustrate an occlusion device 289 having a ratio of smoothcylindrical section 287 height H_(C) to total height H_(T)(ratio=H_(C)/H_(T)) equal to between about 0.40 and about or equal toabout 0.43. The occlusion device 289 has a ratio of curvilinear contour285 height H_(W) to total height H_(T) (ratio=H_(W)/H_(T)) equal tobetween about 0.47 and about 0.55, or equal to about 0.50. The occlusiondevice 289 has a curvilinear contour 285 that extends around an outercircumference of the distal end 283. A maximum diameter D_(M) of theocclusion device 289 occurs at an upper extreme 281 of the smoothcylindrical section 287. A minimum diameter D_(m) of the occlusiondevice 289 occurs at a lower extreme 279 of the smooth cylindricalsection 287. Thus, the smooth cylindrical section 287 is a frustoconicalsurface providing a tapering diameter, that tapers up toward thecurvilinear contour 285. The occlusion device 289 has a ratio of totalheight H_(T) to maximum diameter D_(M) (ratio=H_(T)/D_(M)) equal tobetween about 0.25 and about 0.57, or between about 0.37 and about 0.51,or equal to about 0.42. The occlusion device 289 is formed using a maleform or mold that engages the distal surface 277.

The occlusion devices 268, 282, 294, 289 of FIGS. 3A-6B each comprisecurvilinear contours 272, 286, 298, 285 having four peaks 275 and fourvalleys 273 (see FIG. 3B). However, in alternative embodiments, thecurvilinear contours may comprise two or more peaks 275/two or morevalleys 273 or three or more peaks 275/three or more valleys 273, orfour or more peaks 275/four or more valleys 273, or five or more peaks275/five or more valleys 273, or more. The ratio of curvilinear contourheight H_(W) to total height H_(T) (ratio=H_(W)/H_(T)) may be betweenabout 0.10 to about 0.90, or about 0.25 to 0.75, or about 0.30 to about0.60, or about 0.40 to about 0.60. The total height H_(T) may be betweenabout 1 mm and about 10 mm, or between about 2 mm and about 6 mm, orbetween about 2 mm and about 5 mm. Though the curvilinear contours 272,286, 298, 285 of the occlusion devices 268, 282, 294, 289 extend aroundan outer circumference of the distal end, other embodiments, may havecurvilinear contours that extend across the distal surface as diameters,radii, partial radial lines, chords, or partial chords. In someembodiments, the curvilinear contours may even follow a secondary curve,such that they trace a non-planar path.

In FIGS. 7-10 , an aneurysm 10 having a neck portion 16 is shown. Theocclusion device 200 is shown in use being implanted by a user (e.g.,physician) into the aneurysm 10 through the delivery catheter 150 todisrupt or halt the flow of blood flow between the blood vessel 12 andthe internal volume 14 of the aneurysm, thereby reducing the likelihoodthat the aneurysm 10 will rupture; or, if the aneurysm was previouslyruptured, reducing the likelihood of rerupture. The occlusion device 200is configured to be low profile device, minimizing disruptions tosurrounding bodies, such as a side branch 18 of the blood vessel 12. Theblood vessel 12 has a blood vessel wall 13 and the aneurysm 10 has ananeurysm wall 11. In FIG. 7 , the delivery catheter 150 is advancedthrough a sheath and/or guiding catheter (not shown) through a punctureor cutdown in a peripheral blood vessel, such as a femoral artery, abrachial artery, or a radial artery. The distal end 162 of the deliverycatheter 150 may be shaped with a curve, as shown, either by themanufacturer, or prior to the procedure by the user, in order to allowfor improved backup support when delivering the occlusion device 200.The distal end 162 of the delivery catheter 150 is placed adjacent theneck portion 16 of the aneurysm 10. The delivery catheter 150 may beadvanced over a guidewire (not shown) that is extended through the lumen148. The guidewire may then be removed, leaving the lumen 148 as adelivery conduit and the delivery catheter 150 as a support column.

In FIG. 8 , the occlusion device 200 is advanced through the lumen 148of the delivery catheter 150, as described, and the distal end 230 ofthe occlusion device 200 is advanced out of the lumen 148 and into theinternal volume 14 of the aneurysm 10. The distal end 230 is the firstportion of the occlusion device 200 that exits the lumen 148 and thus isthe first portion of the occlusion device to enter the aneurysm 10. InFIG. 9 , the occlusion device 200 is shown in a substantially expandedconfiguration within the internal volume 14 of the aneurysm 10. Theconvex proximal end 214 is expanded within the aneurysm 10, and coversthe neck portion 16 of the aneurysm.

Also, in FIG. 9 , the detachable joint 225 (see FIG. 8 ) has beendetached, and thus, the distal end 221 of the pusher wire 219 can bepulled into the lumen 148 of the delivery catheter 150. In someembodiments, the delivery catheter 150 is maintained over the detachablejoint 225 during the detachment procedure, to further protect theaneurysm 10. In FIG. 10 , the delivery catheter 150 is removed, and thedeployed occlusion device 200 is in place to begin to occlude theinternal volume 14 of the aneurysm. The curvilinear contours 264 serveto force the smooth cylindrical section 216 radially against the wall 11of the aneurysm 10, with the convex proximal surface 214 positionedaround or against the neck portion 16 and/or against the interiorsurface 15. The dual layer of mesh in the proximal end 202 aids in thedisruption of blood flow into the aneurysm 10, thus causing thrombosisto isolate the internal volume 14 of the aneurysm 10 from blood flowthrough the blood vessel 12. The curvilinear contours 264 can also helpprotect against undesired longitudinal (axial) compaction of theexpanded occlusion device 200 over time, because the spring-like actionof the multiple contours 264 serve as a greater resistance to compactionthan a single, flat surface or single, convex surface. Braided aneurysmocclusion devices can often compact after many thousands or millions ofheartbeats, and thus thousands or millions of cycles of systolicpressure. The cycles can cause deformation that shortens or otherwisecompresses the devices. The curvilinear contours 264 serve to maintainthe shape of the outer layer 212.

An alternative embodiment of the occlusion devices 200, 268, 282, 294,289 from FIGS. 1-6B is illustrated in FIG. 11 . Occlusion device 300 issimilar to the occlusion device 200, including the curvilinear contours364 at the distal end 330, however the inner layer 338 does not followthe contours of the outer layer 312, but instead is a substantiallystraight tubular column. This column may be the outer diameter of theoriginal tubular mesh (as braided), or may be an expanded diameter (asheat formed). The outer diameter may also be minimized by reducing itvia axial stretching of the inner layer 338 of the braided tube prior toheat forming. The inner layer 338 can provide additional column strengthand longitudinal support, which can help to apply a generallylongitudinal force against the aneurysm neck portion 16 with theproximal end 302. By pulling the expanded occlusion device 300proximally, the outer layer 312 engages and grips the interior surface15 of the aneurysm 10, allowing the column-shaped inner layer 338 tomaintain the longitudinal force on the neck portion 16 of the aneurysm10.

FIGS. 12A and 12B illustrate an occlusion device 400 configured forplacement within an aneurysm. The occlusion device 400 comprises aproximal end 402 and a distal end 430, and is constructed of a single,continuous dual layer mesh. Turning to FIG. 13 , the occlusion device400 is constructed from an inverted mesh tube 406 having a first end408, a second end 410, and a wall 409. The inverted mesh tube 406extends on an outer layer 412 from the second end 410 past a proximalconcavity 415 along a convex proximal surface 414 and along a smoothcylindrical section 416 to the distal end 430 of the occlusion device400. The smooth cylindrical section 416 is configured to provide full360° contact with the inner wall of an aneurysm (around the longitudinalaxis 407 of the occlusion device 400), to form a cylindrical closureregion with the aneurysm. The outer diameter of the smooth cylindricalsection 416 may be between about 3 mm to about 15 mm, or between about 3mm and about 7 mm. At the distal end 430, the wall 409 is invertedinwardly at an inversion fold 432, which creates a distal orifice 434and a first internal volume 436 and a second internal volume 463. Thesecond internal volume 463 is inside a formed ball 411 and the firstinternal volume 436 is outside the ball 411, but inside the outer layer412. The wall 409 transitions at the inversion fold 432 from the outerlayer 412 to an inner layer 438 which has contours that are differentfrom that of the outer layer 412, and extends from the distal orifice434 to the first end 408. The inner layer 438 comprises a ball 411having an outer diameter that is less than the outer diameter of thesmooth cylindrical section 416. In some embodiments, the outer diameterof the ball 411 is between about 15% and about 95% of the outer diameterof the smooth cylindrical section 416. In some embodiments, the outerdiameter of the ball 411 is between about 25% and about 75% of the outerdiameter of the smooth cylindrical section 416. In some embodiments, theouter diameter of the ball 411 is between about 33% and about 67% of theouter diameter of the smooth cylindrical section 416. The inner layer438 extends proximally along an inner tube section 413 to the first end408. A marker band 417 is attached over the two layers of wall 409 justdistal to the ends 408, 410 and within the proximal concavity 415. Insome embodiments the marker band 417 is completely within the proximalconcavity 415, and in other embodiments the marker band 417 is partiallywithin the proximal concavity 415, and in still other embodiments themarker band 417 is proximal to the proximal concavity 415. The occlusiondevice 400 is fabricated as an inverted mesh tube 406 having a simplestraight elongate configuration, and is subsequently formed into theshape shown in FIGS. 12-13 and heat set into this shape. For example,the occlusion device 400 may be constructed as a single layer mesh tubeformed of at least some nickel-titanium alloy filaments, and theninverted on itself. The inverted mesh tube 406 may then be placed into adie or mold comprising one or more pieces, to hold it in the shape ofthe occlusion device 400. Then, the occlusion device 400 may besubjected to an elevated temperature and then cooled, to lock in theshape, resulting in an occlusion device 400 having at least somesuperelastic properties. The occlusion device 400 configured to becompressed or compacted within the lumen 148 of a delivery catheter 150(e.g., microcatheter).

In some embodiments, the occlusion device 400 may comprise somenickel-titanium alloy filaments and some radiopaque elements, comprisingplatinum, gold, tantalum, or alloys of any of these or other radiopaquematerials. In some embodiments, the filaments may comprise drawn filledtubes, such as those comprising a nickel-titanium alloy outer wall and aplatinum core. The radiopaque material allows the occlusion device 400to be visible on radiographs or fluoroscopy. The occlusion device 400may be configured by controlling how much radiopaque material is used,by either the ratio of radiopaque filaments to non-radiopaque filaments,or by the amount of platinum core in the drawn filled tubes. In thismanner, the occlusion device 400 can be selectively fabricated to besufficiently visible, but not over visible, e.g., overly bright, suchthat other objects are obscured. In some embodiments, whether any of thefilaments comprise radiopaque materials or not, the marker band 417 maybe attached adjacent the proximal end 402 by adhesive or epoxy bonding,or swaging, welding or other mechanical attachment. The occlusion device400 is detachably coupled at a detachable joint 425 (FIG. 12A) at itsproximal end 402 to a pusher wire 419 having a distal end 421 and aproximal end 423 (FIG. 12B).

The when the occlusion device 400 is in its expanded configuration(FIGS. 12A-13 ) the expanded ball 411 provides an axial support thatresists the distal end 430 from being able to compact toward theproximal end 402 (or vice versa). Braided aneurysm occlusion devices canoften compact after many thousands or millions of heartbeats, and thusthousands or millions of cycles of systolic pressure. The cycles cancause deformation that shortens or otherwise compresses the devices. Theball 411 serves as a central structure that maintains the shape of theouter structure 437 is formed by the outer layer 412.

FIGS. 14-18 illustrate the delivery of the occlusion device 400 from itscompressed state within the lumen 454 of a delivery catheter 450 to itsexpanded state. The delivery into an aneurysm would follow the generalmanner shown in FIGS. 7-10 . FIG. 14 illustrates the distal end 452 ofthe delivery catheter 450. FIG. 15 illustrates the initial delivery ofthe occlusion device 400 out of the lumen 454 of the delivery catheter450 by pushing the pusher wire 419 at its proximal end 423 (FIG. 12B).The distal end 430 of the occlusion device 400 is significantly foldedup within the mostly compressed outer structure 437. As the pusher wire419 is further pushed distally, the occlusion device 400 begins tofurther exit the lumen 454 and expand, as shown in FIG. 16 . Much of thedistal end 430 begins to unfold from within the outer structure 437. Theball 411 can be seen expanding in FIG. 17 , as the pusher wire 419 ispushed and the occlusion device 400 extends further from the lumen 454.The distal end 430 unfolds even more from within the outer structure437. The smooth cylindrical section 416 begins to take a more definiteshape. Finally, as shown in FIG. 18 , the fully expanded occlusiondevice 400 can be seen, without any of the restraints of the lumen 454of the delivery catheter 450. The rolling, folding or unfolding mannerin which the occlusion device 400 compresses and expands allows for afit within a small diameter delivery catheter. An occlusion device 400having a 3 mm to 6 mm expanded outer diameter may fit within the innerlumen of a microcatheter having a 0.023 inch inner diameter, or a 0.021inch inner diameter, or even a 0.017 inch inner diameter.

The proximal end 402 of the occlusion device 400 in its expandedconfiguration has a significantly large proximal ring-shaped meshsurface 441 (FIG. 12A) that is configured to increase flow diversion andto seat and seal against the proximal portion of the aneurysm such asthe portion adjacent the aneurysm neck. Thus, an aneurysm may be fullyoccluded via biological process in a shorter amount of time than manyother devices. The amount of time to full isolation from the bloodcirculation may be significantly less than one year, and may be as soonas four months, or even as soon as three months.

FIG. 19 illustrates an occlusion device 500 that is similar to theocclusion device 400 of FIG. 12A, however the ball 511 has a mushroomshape. The ball 511 also has a diameter that is significantly greaterthan 50% of the diameter of the outer structure 537, and is alsoconfigured to resist compaction between the distal end 530 and theproximal end 502. The proximal concavity 515 extends for the majority ofthe diameter of the occlusion device 500. The smooth cylindrical section516 still includes a significant surface area to seal along the aneurysmwall. Also shown are the inversion fold 532, the distal orifice 534, andthe detachable joint 525.

FIGS. 20 and 21 illustrate an occlusion device 600 configured forplacement within an aneurysm. The occlusion device 600 comprises aproximal end 602 and a distal end 630, and is constructed of a single,continuous dual layer mesh. Turning to FIG. 22 , the occlusion device600 is constructed from an inverted mesh tube 606 having a first end608, a second end 610, and a wall 609. The inverted mesh tube 606extends from the second end 610 past a proximal concavity 615 along aconvex proximal surface 614 and around an outer fold 651 to form aproximal cover 653. The mesh tube 606 extends inward along a distalcover face 655 and folds toward the center at a center fold 657 An outerlayer 612 forms an outer structure 637 and extends along a proximalsurface 659, to a side portion 661 and to the distal end 630 of theocclusion device 600. The convex proximal surface 614 of the cover 653is configured to seal against the aneurysm adjacent the aneurysm wall.The outer diameter of the occlusion device 600 may be between about 3 mmto about 15 mm, or between about 3 mm and about 7 mm. At the distal end630, the wall 609 is inverted inwardly at an inversion fold 632, whichcreates a distal orifice 634 and a first internal volume 636 and asecond internal volume 663. The second internal volume 663 is inside aball 611 formed by an inner layer 638 and the first internal volume 636is outside the ball 611, but inside the outer layer 612. The wall 609transitions at the inversion fold 632 from the outer layer 612 to theinner layer 638 which has contours that are different from that of theouter layer 612, and extends from the distal orifice 634 to the firstend 608. The inner layer 638 comprises the ball 611 having an outerdiameter that is less than the outer diameter of the outer structure637. In some embodiments, the outer diameter of the ball 611 is betweenabout 15% and about 95% of the outer diameter of the outer structure637. In some embodiments, the outer diameter of the ball 611 is betweenabout 25% and about 75% of the outer diameter of the outer structure637. In some embodiments, the outer diameter of the ball 611 is betweenabout 33% and about 67% of the outer diameter of the outer structure637. The inner layer 638 extends proximally along an inner tube section613 to the first end 608. A marker band 617 is attached over the twolayers of wall 609 just distal to the ends 608, 610 and substantiallywithin the proximal concavity 615. The occlusion device 600 isfabricated as an inverted mesh tube 606 having a simple straightelongate configuration, and is subsequently formed into the shape shownin FIGS. 20-22 and heat set into this shape. For example, the occlusiondevice 600 may be constructed as a single layer mesh tube formed of atleast some nickel-titanium alloy filaments, and then inverted on itself.The inverted mesh tube 606 may then be placed into a die or moldcomprising one or more pieces, to hold it in the shape of the occlusiondevice 600. Then, the occlusion device 600 may be subjected to anelevated temperature and then cooled, to lock in the shape, resulting inan occlusion device 600 having at least some superelastic properties.The occlusion device 600 configured to be compressed or compacted withinthe lumen 148 of a delivery catheter 150 (e.g., microcatheter).

In some embodiments, the occlusion device 600 may comprise somenickel-titanium alloy filaments and some radiopaque elements, comprisingplatinum, gold, tantalum, or alloys of any of these or other radiopaquematerials. In some embodiments, the filaments may comprise drawn filledtubes, such as those comprising a nickel-titanium alloy outer wall and aplatinum core. The radiopaque material allows the occlusion device 600to be visible on radiographs or fluoroscopy. The occlusion device 600may be configured by controlling how much radiopaque material is used,by either the ratio of radiopaque filaments to non-radiopaque filaments,or by the amount of platinum core in the drawn filled tubes. In thismanner, the occlusion device 600 can be selectively fabricated to besufficiently visible, but not over visible, e.g., overly bright, suchthat other objects are obscured. In some embodiments, whether any of thefilaments comprise radiopaque materials or not, the marker band 617 maybe attached adjacent the proximal end 602 by adhesive or epoxy bonding,or swaging, welding or other mechanical attachment. As shown in FIGS.20-22 , the marker band 617 can be configured to partially or completelyreside within the proximal concavity 615 when the expanded occlusiondevice 600 is in its expanded configuration. The occlusion device 600 isdetachably coupled at a detachable joint 625 (FIG. 20 ) at its proximalend 602 to a pusher wire 619 having a distal end 621 and a proximal end623.

The when the occlusion device 600 is in its expanded configuration(FIGS. 20-22 ) the expanded ball 611 provides an axial support thatresists the distal end 630 from being able to compact toward theproximal end 602 (or vice versa). Braided aneurysm occlusion devices canoften compact after many thousands or millions of heartbeats, and thusthousands or millions of cycles of systolic pressure. The cycles cancause deformation that shortens or otherwise compresses the devices. Theball 611 serves as a central structure that maintains the shape of theouter structure 637 is formed by the outer layer 612.

FIGS. 23-28 illustrate the delivery of the occlusion device 600 from itscompressed state within the lumen 654 of a delivery catheter 650 to itsexpanded state. The delivery into an aneurysm would follow the generalmanner shown in FIGS. 7-10 . FIG. 23 illustrates the distal end 652 ofthe delivery catheter 650. FIG. 24 illustrates the initial delivery ofthe occlusion device 600 out of the lumen 654 of the delivery catheter650 by pushing the pusher wire 619 at its proximal end 623. The distalend 630 of the occlusion device 600 is significantly folded up withinthe mostly compressed outer structure 637. As the pusher wire 619 isfurther pushed distally, the occlusion device 600 begins to further exitthe lumen 654 and expand, as shown in FIG. 25 . The ball 611 can be seenexpanding in FIG. 26 , as the pusher wire 619 is pushed and theocclusion device 600 extends further from the lumen 654. The distal end630 unfolds more from within the outer structure 637. The outerstructure 637 begins to take a more definite shape, and the cover 653begins to form. In FIG. 27 , the cover 653 begins to take a moredefinite shape, and the ball 611 expands closer to it expanded diameter.Finally, as shown in FIG. 28 , the fully expanded occlusion device 600can be seen, without any of the restraints of the lumen 654 of thedelivery catheter 650. The rolling, folding or unfolding manner in whichthe occlusion device 600 compresses and expands allows for a fit withina small diameter delivery catheter. An occlusion device 600 having a 3mm to 6 mm expanded outer diameter may fit within the inner lumen of amicrocatheter having a 0.023 inch inner diameter, or a 0.021 inch innerdiameter, or even a 0.017 inch inner diameter.

The cover 653 at the proximal end 602 of the occlusion device 600 in itsexpanded configuration has a significantly large proximal ring-shapedmesh surface 641 (FIG. 22 ) that is configured to increase flowdiversion and to seat and seal against the proximal portion of theaneurysm such as the portion adjacent the aneurysm neck. Thus, ananeurysm may be fully occluded via biological process in a shorteramount of time than many other devices. The amount of time to fullisolation from the blood circulation may be significantly less than oneyear, and may be as soon as four months, or even as soon as threemonths.

FIGS. 29-30 illustrate an occlusion device 700 configured for placementwithin an aneurysm. The occlusion device 700 comprises a proximal end702 and a distal end 704, and is constructed of a single, continuousdual layer mesh. The occlusion device 700 is constructed from aninverted mesh tube 706 having a first end 708, a second end 710, and awall 709. The inverted mesh tube 706 extends from the first end 708 pasta proximal concavity 715 along an outer layer 712 comprising a globularcontour 737 having a proximal outer surface 714 and a distal outersurface 716. The proximal outer surface 714 is configured to sealagainst the aneurysm adjacent the aneurysm wall. The outer diameter ofthe occlusion device 700 may be between about 3 mm to about 15 mm, orbetween about 3 mm and about 7 mm. At the distal end 704, the wall 709is inverted inwardly at an inversion fold 732, which creates a distalorifice 734 and a first internal volume 736 and a second internal volume763. The inversion fold also divides the wall 709 into the outer layer712 and an inner layer 738. The second internal volume 763 is inside acolumn 711 formed by the inner layer 738, and the first internal volume736 is outside the column 711, but inside the outer layer 712. The innerlayer 738 has contours that are different from that of the outer layer712, and extends from the distal orifice 734 to the second end 710. Thecolumn 711 extends proximally from the inversion fold 732. The innerlayer 738 comprises the column 711 which has an outer diameter that isless than the outer diameter of the globular contour 737. The column 711includes a circumferentially-extending concavity 735, and thus comprisesa hyperboloid. In some embodiments, the column 711 has a minimumdiameter d_(m) that is between about 5% and about 50% of the maximumdiameter D_(M) of the globular contour 737. In some embodiments, thecolumn 711 has a minimum diameter d_(m) that is between about 5% andabout 25% of the maximum diameter D_(M) of the globular contour 737.

The inner layer 738 extends along the column 711, and then forms aninner cover 720 by extending outward radially along an inner coverdistal face 718 to an inner cover outer face 722. The distal face 718transitions to the outer face 722 at a maximum diameter portion 724. Theouter face 722 tapers to the maximum diameter portion 724, from proximalto distal. However, in alternative embodiments, the outer face 722 mayhave no significant taper, or may even taper in the opposite manner,with the maximum diameter being at or near the proximal end. The innercover 720 then transitions to an inner cover proximal face 726 at aproximal end 728. The proximal face 726 is immediately adjacent theproximal concavity 715 of the outer layer 712, thus creating two layersat the neck portion of the aneurysm, when the occlusion device 700 isdeployed therein. The outer face 722 is immediately adjacent theproximal outer surface 714 of the outer layer 712, thus creating twolayers adjacent the neck portion of the aneurysm. The dual layers at andadjacent the neck of the aneurysm serve to increase the overall densityof the mesh (e.g., the total number of crossings, or the total pics perinch or pics per mm), to thus aid in the disruption or stagnation offlow at the neck. In some embodiments, the column 711 has a minimumdiameter d_(m) that is between about 5% and about 50% of the diameter ofthe maximum diameter portion 724 of the inner cover 720. In someembodiments, the column 711 has a minimum diameter d_(m) that is betweenabout 5% and about 25% of the diameter of the maximum diameter portion724 of the inner cover 720. In some embodiments, the column 711 has alength (proximal to distal, along a longitudinal axis) that is betweenabout 30% and about 150% a length (proximal to distal, along alongitudinal axis) of the inner cover 720. In some embodiments, thecolumn 711 has a length (proximal to distal, along a longitudinal axis)that is between about 50% and about 90% a length (proximal to distal,along a longitudinal axis) of the inner cover 720. In some embodiments,the column 711 has a length (proximal to distal, along a longitudinalaxis) that is between about 50% and about 70% a length (proximal todistal, along a longitudinal axis) of the inner cover 720. In someembodiments, the column 711 has a length (proximal to distal, along alongitudinal axis) that is between about 20% and about 90% a totallength of the occlusion device between the proximal end 702 and thedistal end 704.

The inner layer 738 thus extends from the inversion fold 732, throughthe column 711, and the entirety of the inner cover 720, to the secondend 710. A marker band 717 is attached over the two layers of wall 709just distal to the ends 708, 710. The marker band 717 may comprise aradiopaque material such as platinum, platinum/iridium, or tantalum, forviewing on x-ray or fluoroscopy, as may any of the marker bandsdescribed herein. The occlusion device 700 is fabricated as an invertedmesh tube 706 having a simple straight elongate configuration, and issubsequently formed into the shape shown in FIGS. 29-30 and heat setinto this shape, to create an expanded state. For example, the occlusiondevice 700 may be constructed as a single layer mesh tube formed of atleast some nickel-titanium alloy filaments, and then inverted on itself.The inverted mesh tube 706 may then be placed into a die or moldcomprising one or more pieces, to hold it in the shape of the occlusiondevice 700. Then, the occlusion device 700 may be subjected to anelevated temperature and then cooled, to lock in the shape, resulting inan occlusion device 700 having at least some superelastic properties.The occlusion device 700 configured to be compressed or compacted withinthe lumen 654 of a delivery catheter 650 (e.g., microcatheter), having adistal end 652 (FIGS. 32-36 ).

In the expanded state of the occlusion device 700, the column 711 servesas an internal support to reduce the compressibility of the outer layer712, and thus to maintain the shape of the globular contour 737, eventhroughout long-term implantation within an aneurysm. The column 711,with its larger density of crossings/pics (e.g., smaller average poresize) provides a distal stagnation or flow disruption nidus. The column711 has a significantly smaller pore size than the outer layer 712 whenthe occlusion device 700 is in its expanded state. The column 711 alsohas a significantly smaller pore size than the inner cover 720 when theocclusion device 700 is in its expanded state. In some pre-clinicalstudies performed by the inventors, an almost-immediate thrombosis wasachieved in experimental aneurysms in animals. The thrombosis progressedin a top-down manner, beginning in the distal region of the occlusiondevice 700 that includes the column 720. The efficiency of the flowstagnation or disruption in the distal area of the occlusion device isaided by the complexity provided by the inner column contour, the outerlayer contour, and the density of the crossings/pics in the column. Thecolumn 711 additionally is able to apply an axial force to maintain theinner cover 720 and proximal outer surface 714 against the neck of theaneurysm. Thus, the occlusion device 700 includes a distal stagnationzone DSZ and a proximal stagnation zone PSZ.

In some embodiments, when the occlusion device 700 is in its expandedstate, the outer face 722 of the inner cover 720 may provide an outwardradial stress on the outer layer 712 at an inner portion 748 oppositethe proximal outer surface 714, thus serving to increase the overallradial expansion and/or radial gripping to the aneurysm wall. In otherembodiments, there may be an annular space 750 between the outer face722 of the inner cover 720 and the inner portion 748 (FIG. 37 ). Theannular space 750 may serve multiple purposes. The annular space 750 mayallow for some freedom-of-movement between the outer layer 712 and theinner cover 720. The annular space 750 may also, or alternatively,provide an additional stagnation layer between the outer layer 712 andthe inner cover 720, to increase flow stagnation or disruption. The word“globular” as used herein does not strictly limit to a sphere. Any shapehaving somewhat smooth and/or rounded contours and which displaces aspace having a relatively low surface-to-volume ratio may be considered“globular” for purposes herein. For example, the outer extents of theocclusion device 700 as shown in FIG. 29 and as shown in FIG. 30 areconsidered globular.

The occlusion device 700 is detachably coupled at a detachable joint 740at its proximal end 702 to a pusher wire 742 having a distal end 744 anda proximal end 746. The detachable joint 740 may comprise one of anumber of detachment systems, including but not limited to pressurizeddetachment, electrolytic detachment mechanisms, hydraulic detachmentmechanisms, mechanical or interlocking detachment mechanisms, chemicaldetachment mechanisms, heat-activated detachment systems, or frictionaldetachment systems. In any of the embodiments disclosed herein,alternative detachable joint may be employed, such as the detachablejoints disclosed in U.S. Pat. No. 11,058,431, issued Jul. 13, 2021, andentitled “Systems and Methods for Treating Aneurysms” and in U.S. Pat.No. 10,856,880, issued Dec. 8, 2020, and entitled “Systems and Methodsfor Treating Aneurysms.”

FIGS. 32-36 illustrate the delivery of the occlusion device 700 from itscompressed state within the lumen 654 of a delivery catheter 650 to itsexpanded state. FIG. 32 illustrates the distal end 652 of the deliverycatheter 650. FIG. 33 illustrates the initial delivery of the occlusiondevice 700 out of the lumen 654 of the delivery catheter 650 by pushingthe pusher wire 742 at its proximal end 746. The majority of theocclusion device 700 is still significantly compressed. As the pusherwire 742 is further pushed distally, the occlusion device 700 begins tofurther exit the lumen 654 and expand, as shown in FIG. 34 . The column711 can be seen expanding in FIG. 35 , as the pusher wire 742 is pushedand the occlusion device 700 extends further from the lumen 654. Theglobular contour 737 of the outer layer 712 begins to take a moredefinite shape, and the inner cover 720 significantly beings taking itsshape. In FIG. 36 , the inner cover 720, the globular contour 737, andthe column 711 each take their expanded shapes of the occlusion device700 in its expanded state, without any of the restraints of the lumen654 of the delivery catheter 650. An occlusion device 700 having a 3 mmto 6 mm expanded outer diameter may fit within the inner lumen of amicrocatheter having a 0.023 inch inner diameter, or a 0.021 inch innerdiameter, or even a 0.017 inch inner diameter.

FIG. 31 illustrates an alternative embodiment of an occlusion device739, similar to the device 700 of FIGS. 29-30 , and also comprising aninverted mesh tube having an outer layer 741 and an inner layer 743which transition at a transition fold 745. The transition fold 745 formsa distal orifice 747, and the shapes of the outer layer 741 and innerlayer 743 form a first internal volume 749 and a second internal volume751. In the occlusion device 739 of FIG. 31 , the inner layer 743 formsa distal column 753, and at a proximal portion 755, a first proximalring 757 and a second distal ring 759. A circumferentially extendingconcavity 761 separates the first proximal ring 757 and the seconddistal ring 759. The presence of both rings 757, 759 at the proximalportion 755 of the occlusion device 739 increases the number ofcrossings in the braid, and provides a significant stagnation zone. Thestacking of the rings 757, 759 and the column 753 together createadditional support against axial compaction of the occlusion device 739,e.g., even after many blood pressure cycles.

FIGS. 38-39 illustrate an occlusion device 800 configured for placementwithin an aneurysm. The occlusion device 800 comprises a proximal end802 and a distal end 804, and is constructed of a single, continuousdual layer mesh. The occlusion device 800 is constructed from aninverted mesh tube 806 having a first end 808, a second end 810, and awall 809. The inverted mesh tube 806 extends from the first end 808 pasta proximal concavity 815 along an outer layer 812 which forms a proximalouter cover 814 and a distal outer ball 816. The proximal outer cover814 is configured to seal against the aneurysm adjacent the aneurysmwall. The outer diameter of the proximal outer cover 814 of theocclusion device 800 may be between about 3 mm to about 15 mm, orbetween about 3 mm and about 7 mm. At the distal end 804, the wall 809is inverted inwardly at an inversion fold 832, which creates a distalorifice 834 and a first internal volume 836 and a second internal volume863. The inversion fold also divides the wall 809 into the outer layer812 and an inner layer 838. The second internal volume 863 is inside adistal inner ball 811 formed by the inner layer 838, and the firstinternal volume 836 is outside the distal inner ball 811, but inside thedistal outer ball 816. The inner layer 838 has contours that are similarto that of the outer layer 812, and extends from the distal orifice 834to the second end 810. However, the inner layer 838 does not touch theouter layer 812 throughout its track. The outer diameter d_(o) of thedistal inner ball 811 is less than the inner diameter D₁ of the distalouter ball 816, thus providing the annular, shell-like space thatdefines the first internal volume 836. The distal inner ball 811 extendsproximally from the inversion fold 832. In some embodiments, the distalinner ball 811 has an outer diameter d_(o) that is between about 40% andabout 98% of the outer diameter D_(O) of the distal outer ball 816. Insome embodiments, the distal inner ball 811 has an outer diameter d_(o)that is between about 50% and about 90% of the outer diameter D_(O) ofthe distal outer ball 816. In some embodiments, the distal inner ball811 has an outer diameter d_(o) that is between about 60% and about 80%of the outer diameter D_(O) of the distal outer ball 816.

The inner layer 838 extends along the distal inner ball 811, and thenforms an inner cover 820 by extending outward radially along an innercover distal face 818 to an inner cover outer face 822. The distal face818 transitions to the outer face 822 at a maximum diameter portion 824.The proximal outer cover 814 has a matching distal face 819, outer face823, and maximum diameter portion 825. The outer face 822 of the innercover 820 tapers to the maximum diameter portion 824, from proximal todistal. However, in alternative embodiments, the outer face 822 may haveno significant taper, or may even taper in the opposite manner, with themaximum diameter being at or near the proximal end. The same is possiblewith the proximal outer cover 814. In some embodiments, the proximalouter cover 814 and the inner cover 820 may purposely be non-matching.In other words, the inner cover 820 may have its maximum diameterportion 824 proximally and taper thereto, and the proximal outer cover814 may have its maximum diameter portion distally and taper thereto.The inner cover 820 then transitions to an inner cover proximal face 826at a proximal end 802. The proximal face 826 is immediately adjacent theproximal concavity 815 of the outer layer 812, thus creating two layersat the neck portion of the aneurysm, when the occlusion device 800 isdeployed therein. The outer face 822 and the outer face 823 create twolayers adjacent the neck portion of the aneurysm. The dual layers at andadjacent the neck of the aneurysm serve to increase the overall densityof the mesh (e.g., the total number of crossings, or the total pics perinch or pics per mm), to thus aid in the disruption or stagnation offlow at the neck. In some embodiments, the distal inner ball 811 has alength (proximal to distal, along a longitudinal axis) that is betweenabout 20% and about 90% a total length of the occlusion device betweenthe proximal end 802 and the distal end 804.

The inner layer 838 thus extends from the inversion fold 832, throughthe distal inner ball 811, and the entirety of the inner cover 820, tothe second end 810. A marker band 817 is attached over the two layers ofwall 809 just distal to the ends 808, 810. The marker band 817 maycomprise a radiopaque material such as platinum, platinum/iridium, ortantalum, for viewing on x-ray or fluoroscopy. The occlusion device 800is fabricated as an inverted mesh tube 806 having a simple straightelongate configuration, and is subsequently formed into the shape shownin FIGS. 38-39 and heat set into this shape, to create an expandedstate. For example, the occlusion device 800 may be constructed as asingle layer mesh tube formed of at least some nickel-titanium alloyfilaments, and then inverted on itself. The inverted mesh tube 806 maythen be placed into a die or mold comprising one or more pieces, to holdit in the shape of the occlusion device 800. Then, the occlusion device800 may be subjected to an elevated temperature and then cooled, to lockin the shape, resulting in an occlusion device 800 having at least somesuperelastic properties. The occlusion device 800 configured to becompressed or compacted within the lumen 654 of a delivery catheter 650(e.g., microcatheter), having a distal end 652.

In the expanded state of the occlusion device 800, the distal inner ball811 serves as an internal support to reduce the compressibility of theouter layer 812, and thus to maintain the shape of the distal outer ball816, even throughout long-term implantation within an aneurysm. Thedistal inner ball 811, may comprise a larger density of crossings/pics(e.g., smaller average pore size) than the distal outer ball 816, tohelp increase distal stagnation or flow disruption nidus. The distalinner ball 811 may have a significantly smaller pore size than thedistal outer ball 816 when the occlusion device 800 is in its expandedstate. The distal inner ball 811 may also have a significantly smallerpore size than the proximal outer cover 814 and/or the inner cover 820when the occlusion device 800 is in its expanded state. Thus, theocclusion device 800 may include a distal stagnation zone (balls 811,816) and a proximal stagnation zone (covers 814, 820).

In some embodiments, when the occlusion device 800 is in its expandedstate, the inner cover 820 may provide an outward radial stress on thedistal outer cover 814, somewhat similar to what was previouslydescribed in relation to the occlusion device 700, thus serving toincrease the overall radial expansion and/or radial gripping to theaneurysm wall. In other embodiments, there may be an annular spacebetween the inner cover 820 and the distal outer cover 814, as describedin relation to FIG. 37 . The ball shape of either ball 811, 816 may be“globular” as broadly defined herein.

The occlusion device 800 is detachably coupled at a detachable joint 840at its proximal end 802 to a pusher wire 842 having a distal end 844 anda proximal end 846. The detachable joint 840 may comprise one of anumber of detachment systems, including but not limited to pressurizeddetachment, electrolytic detachment mechanisms, hydraulic detachmentmechanisms, mechanical or interlocking detachment mechanisms, chemicaldetachment mechanisms, heat-activated detachment systems, or frictionaldetachment systems. In any of the embodiments disclosed herein,alternative detachable joint may be employed, such as the detachablejoints disclosed in U.S. Pat. No. 11,058,431, issued Jul. 13, 2021, andentitled “Systems and Methods for Treating Aneurysms” and in U.S. Pat.No. 10,856,880, issued Dec. 8, 2020, and entitled “Systems and Methodsfor Treating Aneurysms.”

FIGS. 40-46 illustrate the delivery of the occlusion device 800 from itscompressed state within the lumen 654 of a delivery catheter 650 to itsexpanded state. FIG. 40 illustrates the distal end 652 of the deliverycatheter 650. FIG. 41 illustrates the initial delivery of the occlusiondevice 800 out of the lumen 654 of the delivery catheter 650 by pushingthe pusher wire 842 at its proximal end 846. The majority of theocclusion device 800 is still significantly compressed. As the pusherwire 842 is further pushed distally, the occlusion device 800 begins tofurther exit the lumen 654 and expand, as shown in FIG. 42 . The distalinner ball 811 can be seen expanding in FIG. 42 and FIG. 43 , as thepusher wire 842 is pushed and the occlusion device 800 extends furtherfrom the lumen 654. In FIG. 44 , the outer layer 812 begins to take amore definite shape, although the proximal outer cover 814 is stillexiting the lumen 654. In FIG. 45 , the occlusion device 800 is extendeda bit more. In FIG. 46 , the proximal outer cover 814 and the two balls811, 816 each take their expanded shapes of the occlusion device 800 inits expanded state, without any of the restraints of the lumen 654 ofthe delivery catheter 650. An occlusion device 800 having a 3 mm to 6 mmexpanded outer diameter may fit within the inner lumen of amicrocatheter having a 0.023 inch inner diameter, or a 0.021 inch innerdiameter, or even a 0.017 inch inner diameter.

FIGS. 47-48 illustrate an occlusion device 900 configured for placementwithin an aneurysm. The occlusion device 900 comprises a proximal end902 and a distal end 904, and is constructed of a single, continuousdual layer mesh. The occlusion device 900 is constructed from aninverted mesh tube 906 having a first end 908, a second end 910, and awall 909. The inverted mesh tube 906 extends from the first end 908 pasta proximal face 915 along an outer layer 912 which forms a proximalouter cover 914 and a distal outer dome 916. The proximal outer cover914 is configured to seal against the aneurysm adjacent the aneurysmwall. The outer diameter of the proximal outer cover 914 of theocclusion device 900 may be between about 3 mm to about 15 mm, orbetween about 3 mm and about 7 mm. The distal outer dome 916 maycomprise a hemisphere or a partial portion of a sphere, or a partialportion of any globular shape, as defined broadly herein. At the distalend 904, the wall 909 is inverted inwardly at an inversion fold 932,which creates a distal orifice 934 and a first internal volume 936 and asecond internal volume 963. The inversion fold also divides the wall 909into the outer layer 912 and an inner layer 938. The second internalvolume 963 is inside an inner bell shape 911 (or mushroom shape) formedby the inner layer 938, and the first internal volume 936 is outside theinner bell shape 911, but inside the distal outer dome 916. The innerlayer 938 has a contour that is similar to that of the outer layer 912only at an inner band area 901 that is inside a waist portion 903 of theouter layer 912 that is between the proximal outer cover 914 and thedistal outer dome 916. The inner layer 938 extends from the distalorifice 934 to the second end 910. The maximum outer diameter d_(ob) ofthe inner bell shape 911 is less than the inner diameter D_(IC) of theproximal outer cover 914, thus providing a third internal volume 905,which is substantially annular. The inner bell shape 911 extendsproximally from the inversion fold 932. In some embodiments, the innerbell shape 911 has a maximum outer diameter d_(ob) that is between about30% and about 98% of an outer diameter D_(OC) of the proximal outercover 914. In some embodiments, the inner bell shape 911 has a maximumouter diameter d_(ob) that is between about 50% and about 90% of theouter diameter D_(OC) of the proximal outer cover 914. In someembodiments, the inner bell shape 911 has a maximum outer diameterd_(ob) that is between about 60% and about 85% of the outer diameterD_(OC) of the proximal outer cover 914.

In some embodiments, the outer diameter D_(OC) of the proximal outercover 914 is about the same as an outer diameter D_(OD) of the distalouter dome 916. In some embodiments, the outer diameter D_(OC) of theproximal outer cover 914 is smaller than the outer diameter D_(OD) ofthe distal outer dome 916. In some embodiments, the outer diameterD_(OC) of the proximal outer cover 914 is larger than the outer diameterD_(OD) of the distal outer dome 916.

The outer waist 903 has an opposite inner face 907 that matches thecontour of the inner bell shape 911 at the inner band area 901, althoughin other embodiments, a significant annular space may be present, and/orthe contours may not match each other. In some embodiments, includingthe embodiment shown in FIG. 48 , axial compression (e.g., from theaneurysm dome or from blood pressure) on the distal outer dome 916 ofthe occlusion device 900 if centered longitudinally can force a proximalface 913 of the inner bell shape 911 against an inner face 921 of theproximal outer cover 914, thus centering a force against the neck of theaneurysm. This is because the tapered contours of the inner face 907 andthe inner band area 901 create annular space from each other as theinner bell shape 911 moves down in relation to the proximal outer cover914. If instead, the axial compression from more of an outer portion ofthe aneurysm dome act on the distal outer dome 916, the inner face 907and the inner band area 901 can engage each other, this transmitting thedownward force onto both the inner bell shape 911 and the proximal face915. The taper and other contours of the inner bell shape 911 and thewaist area 903 can thus be modified, to control the amount of mechanicalengagement between the outer layer 912 and the inner layer 938. Theshape of the inner bell shape 911 (e.g., length vs. diameter or angle oftaper, etc.) can be adjusted to control the amount of compressiveresistance in the occlusion device 900 (e.g., resistance to compactionfrom blood pressure cycling). The proximal face 915 and the proximalface 913 create two layers adjacent the neck portion of the aneurysm.The dual layers at and adjacent the neck of the aneurysm serve toincrease the overall density of the mesh (e.g., the total number ofcrossings, or the total pies per inch or pies per mm), to thus aid inthe disruption or stagnation of flow at the neck.

A marker band 917 is attached over the two layers of wall 909 justdistal to the ends 908, 910. The marker band 917 may comprise aradiopaque material such as platinum, platinum/iridium, or tantalum, forviewing on x-ray or fluoroscopy. The occlusion device 900 is fabricatedas an inverted mesh tube 906 having a simple straight elongateconfiguration, and is subsequently formed into the shape shown in FIGS.47-48 and heat set into this shape, to create an expanded state. Forexample, the occlusion device 900 may be constructed as a single layermesh tube formed of at least some nickel-titanium alloy filaments, andthen inverted on itself. The inverted mesh tube 906 may then be placedinto a die or mold comprising one or more pieces, to hold it in theshape of the occlusion device 900. Then, the occlusion device 900 may besubjected to an elevated temperature and then cooled, to lock in theshape, resulting in an occlusion device 900 having at least somesuperelastic properties. The occlusion device 900 configured to becompressed or compacted within the lumen 654 of a delivery catheter 650(e.g., microcatheter), having a distal end 652.

In the expanded state of the occlusion device 900, the inner bell shape911 serves as an internal support to reduce the compressibility of theouter layer 812, and thus to maintain the shape of the entire expandedportion of the occlusion device 900, even through long-term implantationwithin an aneurysm. The inner bell shape 911, may comprise a largerdensity of crossings/pies (e.g., smaller average pore size) than theproximal outer cover 914 and/or the distal outer dome 916, to helpincrease distal stagnation or flow disruption nidus. The inner bellshape 911 may have a significantly smaller pore size than the proximalouter cover 914 and/or the distal outer dome 916 when the occlusiondevice 900 is in its expanded state. Thus, the occlusion device 900 mayinclude a distal stagnation zone (inner bell shape 911 and distal outerdome 916) and a proximal stagnation zone (inner bell shape 911 andproximal outer cover 914).

The occlusion device 900 is detachably coupled at a detachable joint 940at its proximal end 902 to a pusher wire 942 having a distal end 944 anda proximal end 946. The detachable joint 940 may comprise one of anumber of detachment systems, including but not limited to pressurizeddetachment, electrolytic detachment mechanisms, hydraulic detachmentmechanisms, mechanical or interlocking detachment mechanisms, chemicaldetachment mechanisms, heat-activated detachment systems, or frictionaldetachment systems. In any of the embodiments disclosed herein,alternative detachable joint may be employed, such as the detachablejoints disclosed in U.S. Pat. No. 11,058,431, issued Jul. 13, 2021, andentitled “Systems and Methods for Treating Aneurysms” and in U.S. Pat.No. 10,856,880, issued Dec. 8, 2020, and entitled “Systems and Methodsfor Treating Aneurysms.”

FIGS. 49-56 illustrate the delivery of the occlusion device 900 from itscompressed state within the lumen 654 of a delivery catheter 650 to itsexpanded state. FIG. 49 illustrates the distal end 652 of the deliverycatheter 650. FIG. 50 illustrates the initial delivery of the occlusiondevice 900 out of the lumen 654 of the delivery catheter 650 by pushingthe pusher wire 942 at its proximal end 946. The majority of theocclusion device 900 is still significantly compressed. As the pusherwire 942 is further pushed distally, the occlusion device 900 begins tofurther exit the lumen 654 and expand, as shown in FIG. 51 . The innerbell shape 911, the distal outer dome 916, and the proximal outer cover914 can be seen expanding in FIGS. 52-55 , respectively. In FIG. 56 ,the inner bell shape 911, the distal outer dome 916, and the proximalouter cover 914 each take their expanded shapes of the occlusion device900 in its expanded state, without any of the restraints of the lumen654 of the delivery catheter 650. An occlusion device 900 having a 3 mmto 6 mm expanded outer diameter may fit within the inner lumen of amicrocatheter having a 0.023 inch inner diameter, or a 0.021 inch innerdiameter, or even a 0.017 inch inner diameter.

FIG. 57 illustrates an embodiment of a mesh occlusion device 960 havingfeatures that may be utilized in any of the other occlusion devices 200,300, 400, 500, 600, 700, 800, 900 disclosed herein. The occlusion device960 has a proximal end 968 and a distal end 970 and is attached to adistal end 964 of a pusher wire 962 via a marker band 972 and adetachable joint 966, as previously described herein in relation to theother embodiments. A central circle of the proximal end 968 comprises apolymeric seal 974 that fills the adheres to and/or covers theindividual wires or filaments comprising the mesh (e.g., inverted meshtube). In some embodiments, the polymer seal 974 comprises polyurethane.In some embodiments, the polymer seal 974 comprises other thermoplasticelastomers, or comprises non-thermoplastic elastomers. In someembodiments, the polymer seal 974 comprises PTFE, PETE, or otherfluoropolymers. In some embodiments, the polymer seal 974 comprises abioabsorbable polymer. Though the diameter of the polymer seal 974 shownin FIG. 57 is less than the maximum diameter of the proximal end 968 ofthe occlusion device 960, in other embodiments, the diameter of thepolymer seal 974 may include substantially the entire diameter of theproximal end 968, and may in some embodiments, even continue onto aportion of the outer diameter (e.g., lateral cylindrical wall) of thedevice 960. The thickness of the polymer seal 974 (e.g., coatingthickness) may range between about 5 microns to about 2,000 microns. Thepolymer seal 974 serves to significantly stop flow through at least aportion of the proximal end 968 of the occlusion device 960, furtherstagnating blood flow into the aneurysm when the occlusion device 960 isimplanted.

While the foregoing is directed to embodiments of the presentdisclosure, other and further embodiments may be devised withoutdeparting from the basic scope thereof. The filament diameter of thefilaments comprising any of the mesh material (e.g., mesh tube includinginverted mesh tubes) described herein may be between about 0.0004 inchand about inch, or between about 0.0005 inch and about 0.002 inch, orbetween about 0.0006 inch and about 0.002 inch, or between about 0.0006inch and about 0.0015 inch. The drawn filled tubes (DFT) may comprisebetween 0% and 100% of the total strands/filaments in any of thebraided/mesh tubes. In some embodiments, the drawn filled tubes (DFT)comprise about 50% to about 100% of the total filaments of the cover andabout 50% to about 100% of the total filaments of each of thedoubled-over or looped tubular mesh. The radiopaque core of each of atleast some of the drawn filled tubes has a cross-sectional area that isbetween about 10% and about 70% of the total cross-sectional area of theeach of at least some of the drawn filled tubes, or between about 51%and about 70% of the total cross-sectional area of the each of at leastsome of the drawn filled tubes. In some embodiments, NiTi #1-DFT® wireproduced by Fort Wayne Metals Research Products Corp. (Fort Wayne, INUSA) may be utilized. The filaments may be braided with patterns havingfilament crossings that are in any one or more of the following ratiosof filaments: 1×1, 1×2, 2×1, 2×2, 2×3, 3×2, 3×3, etc. (e.g., warp andweft). Any low, moderate, or high pick counts may be used, for example,between about 15 picks per inch and about 300 picks per inch, or betweenabout 20 picks per inch and about 160 picks per inch. Any of thefilaments or any of the portion of the occlusion devices may be coatedwith compounds that enhance endothelialization, thus improving thehealing process when implanted within the aneurysm, and optimizingocclusion. The pusher and occlusion device configurations presentedherein may also be used for in other types of implantable devices, suchas stents, flow diversion devices, filters, and occlusion devices forstructural heart defects.

Additional materials may be carried on the cover of the occlusiondevice, or any other proximal portion of the occlusion device, andconfigured to face opposite the aneurysm neck. In some embodiments, thematerial on the occlusion device may comprise a biological layer,configured to encourage growth. In some embodiments, the biologicallayer may comprise antibodies, in order to accelerate the formation ofan endothelial layer, for example, by attracting endothelial progenitorcells (EPCs). In some embodiments, the biological layer may comprise anatural membrane or structure, such as a membrane, such as a membranefrom an ear, or a cornea, or an ultra-thin piece of ligament, or even apiece of blood vessel wall. In some embodiments, the material on theocclusion device may comprise a polymer layer configured to act as asimulated arterial wall. In some embodiments, the polymer layer maycomprise polytetrafluoroethylene, such as expandedpolytetrafluoroethylene (ePTFE), such as that used in grafts. Occlusiondevices as described herein may incorporate biological or polymericlayers, such as those described in co-pending U.S. Pat. No. 11,202,636,issued Dec. 21, 2021, and entitled “Systems and Methods for TreatingAneurysms,” which is hereby incorporated by reference in its entiretyfor all purposes.

The delivery catheter may be a microcatheter having a luminal diameterof 0.017 inch or 0.021 inch, 0.025 inch, or 0.028 inch, or other sizes.An elongate pusher may comprise a wire, a hypo tube, or another elongatestructure having column support, and is detachably coupled at its distalend to the proximal end of the occlusion device. A detachable joint maycomprise one of a number of detachment systems, including but notlimited to pressurized detachment, electrolytic detachment mechanisms,hydraulic detachment mechanisms, mechanical or interlocking detachmentmechanisms, chemical detachment mechanisms, heat-activated detachmentsystems, or frictional detachment systems.

In any of the braided embodiments, braided elements can be subsequentlyetched (chemical etch, photochemical etch) to decrease the overall wirediameter and decrease the stiffness.

Though multiple embodiments have been presented, other embodiments arepossible using the teachings herein by combining any of the features.For example, a device having the curvilinear contours 264, 364 along thedistal surface 260 may also be constructed having any of the shapes ofthe inner layer of the two-layer braid, such as those shown in theembodiments of FIG. 1, 12A, 19, 20, 29, 31, 38, 47 , or 57 (or occlusiondevices 300, 400, 500, 600, 700, 800, 900, 960). Furthermore, a devicehaving the curvilinear contours 264, 364 along the distal surface 260may also be constructed having any of the shapes of the outer layer ofthe two-layer braid, such as those shown in the embodiments of FIG. 1,12A, 19, 20, 29, 31, 38, 47 , or 57 (or occlusion devices 300, 400, 500,600, 700, 800, 900, 960). Or, as another example, a ball 611 and adistal column 753 may be formed longitudinally adjacent each other on aninner layer. In some embodiments, the ball 611 may be proximal to thedistal column, but in other embodiments a ball may actually be placeddistal to a column. In case wherein any features may appear to beuncombinable, based on the particular embodiments presented herein, theymay nevertheless be combinable by simply changing one or moredimensions, to allow them to fit or morph together.

The ranges disclosed herein also encompass any and all overlap,sub-ranges, and combinations thereof. Language such as “up to,” “atleast,” “greater than,” “less than,” “between,” and the like includesthe number recited. Numbers preceded by a term such as “approximately”,“about”, and “substantially” as used herein include the recited numbers(e.g., about 10%=10%), and also represent an amount close to the statedamount that still performs a desired function or achieves a desiredresult. For example, the terms “approximately”, “about”, and“substantially” may refer to an amount that is within less than 10% of,within less than 5% of, within less than 1% of, within less than 0.1%of, and within less than 0.01% of the stated amount.

For purposes of the present disclosure and appended claims, theconjunction “or” is to be construed inclusively (e.g., “an apple or anorange” would be interpreted as “an apple, or an orange, or both”; e.g.,“an apple, an orange, or an avocado” would be interpreted as “an apple,or an orange, or an avocado, or any two, or all three”), unless: (i) itis explicitly stated otherwise, e.g., by use of “either . . . or,” “onlyone of,” or similar language; or (ii) two or more of the listedalternatives are mutually exclusive within the particular context, inwhich case “or” would encompass only those combinations involvingnon-mutually-exclusive alternatives. For purposes of the presentdisclosure and appended claims, the words “comprising,” “including,”“having,” and variants thereof, wherever they appear, shall be construedas open-ended terminology, with the same meaning as if the phrase “atleast” were appended after each instance thereof.

What is claimed is:
 1. An apparatus for treating an aneurysm in a bloodvessel, comprising: an occlusion element configured to be releasablycoupled to an elongate delivery shaft and configured to be delivered ina collapsed configuration through an inner lumen of a delivery catheter,the occlusion element comprising an inverted mesh tube having an outerlayer and an inner layer, the outer layer transitioning to the innerlayer at an inversion fold, wherein at least the outer layer is formedinto a first expanded shape comprising: a smooth outer cylinderconfigured to engage a wall of an aneurysm throughout a 360°circumference; and a substantially distal-facing surface comprising aplurality of heat-formed three-dimensional surface contours, theplurality of surface contours including at least a first contourcomprising a convex peak and second contour comprising a concave peak,the second contour adjacent the first contour, wherein the first andsecond contours are together configured to apply a radial bias with theouter cylinder.
 2. The apparatus of claim 1, wherein the plurality ofsurface contours comprises a curvilinear contour that extends around anouter circumference substantially encircling the distal-facing surface.3. The apparatus of claim 1, wherein the plurality of surface contoursextends along a diameter of the distal-facing surface.
 4. The apparatusof claim 1, wherein the plurality of surface contours extends along aradius of the distal-facing surface.
 5. The apparatus of claim 1,wherein the plurality of surface contours extends along a chord of thedistal-facing surface.
 6. The apparatus of claim 1, wherein theplurality of surface contours extends along a partial radius of thedistal-facing surface.
 7. The apparatus of claim 1, wherein theplurality of surface contours extends along a partial chord of thedistal-facing surface.
 8. The apparatus of claim 1, wherein theplurality of surface contours includes a surface contour having asinusoidal wave shape.
 9. The apparatus of claim 1, wherein theplurality of surface contours includes a surface contour comprising awave shape having an increasing frequency along a wave axis.
 10. Theapparatus of claim 1, wherein the plurality of surface contours includesa surface contour comprising a wave shape comprising a plurality ofpeaks having substantially equal peak heights.
 11. The apparatus ofclaim 1, wherein the plurality of surface contours includes a surfacecontour comprising a wave shape comprising a plurality of peaks havingpeak heights that decrease along a wave axis.
 12. The apparatus of claim1, wherein the occlusion element further comprises: a proximalconcavity.
 13. The apparatus of claim 1, wherein the outer cylinderdefines a frustoconical surface.
 14. The apparatus of claim 13, whereinthe occlusion element has a maximum diameter at a portion of thefrustoconical surface that is adjacent the distal-facing surface. 15.The apparatus of claim 1, wherein the occlusion element has a totalheight and a maximum diameter, and wherein a total height to maximumdiameter ratio is between about 0.25 and about 0.57.
 16. An apparatusfor treating an aneurysm in a blood vessel, comprising: an occlusionelement configured to be releasably coupled to an elongate deliveryshaft and configured to be delivered in a collapsed configurationthrough an inner lumen of a delivery catheter, the occlusion elementcomprising an inverted mesh tube having an outer layer and an innerlayer, the outer layer transitioning to the inner layer at an inversionfold, wherein at least the outer layer is formed into a first expandedshape comprising: an outer lateral surface extending around theocclusion element; and a substantially distal-facing surface comprisinga plurality of heat-formed three-dimensional surface contours, theplurality of surface contours including at least a first contourcomprising a convex peak and second contour comprising a concave peak,the second contour adjacent the first contour, wherein the first andsecond contours are together configured to apply a radial bias with theouter lateral surface.
 17. The apparatus of claim 16, wherein theplurality of surface contours comprises a curvilinear contour thatextends around an outer circumference substantially encircling thedistal-facing surface.
 18. The apparatus of claim 16, wherein theplurality of surface contours extends along a diameter of thedistal-facing surface.
 19. The apparatus of claim 16, wherein theplurality of surface contours extends along a radius of thedistal-facing surface.
 20. The apparatus of claim 16, wherein theplurality of surface contours extends along a chord of the distal-facingsurface.
 21. The apparatus of claim 16, wherein the plurality of surfacecontours extends along a partial radius of the distal-facing surface.22. The apparatus of claim 16, wherein the plurality of surface contoursextends along a partial chord of the distal-facing surface.
 23. Theapparatus of claim 16, wherein the plurality of surface contoursincludes a surface contour having a sinusoidal wave shape.
 24. Theapparatus of claim 16, wherein the plurality of surface contoursincludes a surface contour comprising a wave shape having an increasingfrequency along a wave axis.
 25. The apparatus of claim 16, wherein theplurality of surface contours includes a surface contour comprising awave shape comprising a plurality of peaks having substantially equalpeak heights.
 26. The apparatus of claim 16, wherein the plurality ofsurface contours includes a surface contour comprising a wave shapecomprising a plurality of peaks having peak heights that decrease alonga wave axis.
 27. The apparatus of claim 16, wherein the occlusionelement further comprises: a proximal concavity.
 28. The apparatus ofclaim 16, wherein the outer lateral surface is a frustoconical surface.29. The apparatus of claim 28, wherein the occlusion element has amaximum diameter at a portion of the frustoconical surface that isadjacent the distal-facing surface.
 30. The apparatus of claim 16,wherein the occlusion element has a total height and a maximum diameter,and wherein a total height to maximum diameter ratio is between about0.25 and about 0.57.